BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DYNAMIS™ Implant System

    Reg #: 3030400539 · FEI: 3030400539 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PROMETHEAN RESTORATIVE
    Registration Number
    3030400539
    FEI Number
    3030400539
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    333 Perry St Ste 210
    City
    Castle Rock
    State
    CO
    ZIP
    80104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243565

    Owner / Operator

    Firm Name
    Promethean Restorative
    Operator Number
    10090289
    Address
    333 Perry Street, Suite 210
    City
    Castle Rock
    State
    CO
    Postal Code
    80104
    Country
    US
    Correspondent
    Glenn Bowman

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR
    Screw, Fixation, Bone HWC

    Proprietary Names

    DYNAMIS™ Implant System DYNAMIS™ SI Screw System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility